Federal Agency for Medicines and Health Products (FAMHP)
famhp.be
Imported from official source
Regulator in Belgium; safety publications from its own official source.
Publications 10
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Tepkinly
Tepkinly Active substance Epcoritamab Holder AbbVie Belgium SA/NV Status Running Indication Epcoritamab in combination with lenalidomide and rituximab (R²) for the treatment of relapsed or refracto...
Announcement -
PRAC september 2026: veiligheidsonderzoek naar injecteerbare ijzerhoudende geneesmiddelen
During its September 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has started the review of injectable iron-containing medicines. The review will a...
Announcement -
Nouveau guide destiné aux promoteurs pour la procédure synchronisée des études combinées CTR–MDR/IVDR
New guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies Publication date 14/09/2026 emily.clayton Mon, 09/14/2026 - 08:58 A new guidance for sponsors on the synchr...
Announcement -
Guide destiné aux promoteurs pour la procédure synchronisée des études combinées CTR–MDR/IVDR
Guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies Belgium offers a synchronised submission procedure for combined studies involving medicinal products and medica...
Announcement -
Enregistrement des antibiotiques dans VAMREG : e-learning pour les vétérinaires
Since 1 July 2026, the use of antibiotics in all horses and aquaculture fish (intended for food production) must be recorded in the VAMREG application. The FAMHP and AMCRA are offering an e-learnin...
Announcement -
50 ans de pharmacovigilance en Belgique : Save the Date
50 years of pharmacovigilance in Belgium: save the date Publication date 02/09/2026 Virone.Letizia Wed, 09/09/2026 - 14:31 The Federal Agency for Medicines and Health Products (FAMHP) is pleased to...
Announcement -
Dépassements de quotas : l’AFMPS poursuit ses travaux et renforce la transparence
Following the press articles published today concerning a new case of quota exceedance involving a foreign gamete donor, as well as the publication of the relevant information on its website, the F...
Announcement -
À partir du 1e septembre 2026 : nouvelle version du formulaire de demande d'autorisation de mise sur le marché pour les procédures nationales, de reconnaissance mutuelle et décentralisées
Applicants and marketing authorisation holders can now use the new version (1.28.0.0) of the Marketing Authorisation Application Form for national, mutual recognition and decentralised procedures. ...
Announcement -
Actualisering van de lijst van essentiële stoffen voor voedselproducerende paarden
On 27 July 2026, Implementing Regulation (EU) 2026/1810 was published concerning the update of the list of essential substances for food-producing horses. This Regulation entered into force on the ...
Announcement -
Model van diergeneeskundig voorschrift: nieuwe verplichte vermeldingen
Since January 2022 veterinarians have the obligation to use a new model for veterinary prescriptions. This new model is being introduced in several stages. Since 1 July 2026, the animal species mus...
Announcement